FOTOFACIAL DEVELOPED BY DR. PATRICK BITTER, JR.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for FOTOFACIAL DEVELOPED BY DR. PATRICK BITTER, JR. manufactured by Sciton Inc..

Event Text Entries

[102204340] I had two ipl/bbl treatments. Specifically, they were sciton fotofacial bbl treatments with dr (b)(6) md (predominantly to attempt to reduce redness in my facial skin that had been caused by fluorouracil topical treatment but also to attempt to make it overall more clear). I'm cautious by nature with medical treatment, so i drove over 200 miles round trip to be treated by dr bitter, who developed bbl broadband light (fotofacial) himself. Bbl is a type of ipl. Ipl stands for intense pulsed light. Bbl stands for broadband light. The treatments were done on (b)(6) 2017 and (b)(6) 2017. I didn't notice any adverse effects in the weeks or months after the (b)(6) 2017 treatment performed by (b)(6), rn. On (b)(6) 2017, three weeks after the second ((b)(6) 2017) treatment performed by dr (b)(6), i noticed both obvious facial fat atrophy and obvious/visible pore size on my face. I had never had visible pores on my face before. And i had normal fat atrophy that occurs with everyone as they age, but post-treatment this was more obvious, noticeable, accelerated. Pre-treatment i researched and saw no drs stating that this treatment can cause facial fat atrophy and/or cause enlarged pores. I found a lot of info indicating that this was a pretty benign treatment with regard to potential side effects, that side effects were minimal. I've since specifically researched facial fat atrophy with ipl/bbl treatments and found many individuals who claim to have had the same adverse effects as i did of enlarged pore size and facial fat loss/atrophy (despite many drs still claiming this is impossible when asked the specific question about ipl/bbl, causing fat loss). Dr (b)(6) is the only dr i have seen state that he believes ipl can cause facial fat loss: (b)(6). Com/fat-grafting/correcting-fat-loss-in-ipl-damage-my-thoughts. My goal is simply to make it mandatory that these potential adverse side effects be disclosed to pts pre-treatment so that they can make informed medical decisions.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5075802
MDR Report Key7330441
Date Received2018-03-09
Date of Report2018-03-08
Date of Event2017-12-25
Date Added to Maude2018-03-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameFOTOFACIAL DEVELOPED BY DR. PATRICK BITTER, JR.
Generic NameBBL
Product CodeORK
Date Received2018-03-09
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSCITON INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-09

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